Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K950852
Device Name CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
Applicant
H.S. Intl. Co., Inc.
5040 Commercial Cir., Unit A
Concord,  CA  94520
Applicant Contact HENRY SHAPIRO
Correspondent
H.S. Intl. Co., Inc.
5040 Commercial Cir., Unit A
Concord,  CA  94520
Correspondent Contact HENRY SHAPIRO
Regulation Number886.4150
Classification Product Code
HQE  
Date Received02/27/1995
Decision Date 05/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-